Cannula 12mm SS, Non-Sterile 3910142.012

GUDID B154R39101420120

Cannula 12mm Stainless Steel, Non-Sterile

WATERS MEDICAL SYSTEMS, LLC

Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set

• Primary Device ID: B154R39101420120
• NIH Device Record Key: 7ba13059-af09-44cb-99a2-1663cd505061
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannula 12mm SS, Non-Sterile
• Version Model Number: 12mm SS
• Catalog Number: 3910142.012
• Company DUNS: 556957871
• Company Name: WATERS MEDICAL SYSTEMS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 507-288-7777
• Email: info@wtrs.com
• Phone: 507-288-7777
• Email: info@wtrs.com

Device Dimensions

• Lumen/Inner Diameter: 12 Millimeter
• Lumen/Inner Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B154R39101420120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971571

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B154R39101420120]

Moist Heat or Steam Sterilization

[B154R39101420120]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-21
• Device Publish Date: 2018-05-02

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